- Device
- VISITAG SURPOINT™ External Processing Unit (“EPU”); CARTO 3 System
- Applicant
- Biosense Webster, Inc.
- PMA number
- P030031
- Supplement
- S143
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2026-06-30
- Decision code
- APPR
- Date received
- 2026-04-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the Connection Interface Unit (CIU) to be used with the TRUPULSE™ Generator, to introduce a predetermined change control plan (PCCP) (Predetermined Change Control Plan TRUPULSE™ Generator System Version 1.0) for planned hardware and software changes to the TRUPULSE™ Generator and related labeling updates